The Center for Drug Evaluation (CDE) website indicates that the market filing by China-based Shenzhen ScienCare Pharmaceutical Co., Ltd for its naltrexone implant has been prioritized for review. The drug, used to prevent relapse among opioid-dependent patients after detoxification, was awarded priority status as a “breakthrough therapy.” This marks a significant step forward in the development of innovative treatments for drug addiction.
Company Background and Pipeline
Founded in 2017, ScienCare Pharma focuses on developing products for drug addiction and mental illnesses. The company’s core product, the SK1801 naltrexone super-long implant, is an opioid receptor antagonist with a binding activity more than 30 times that of heroin. When the concentration of naltrexone in the body reaches a certain level, it effectively antagonizes most opioid receptors, preventing heroin and other drugs from producing euphoria and thus reducing the risk of relapse. Currently, no naltrexone implant dosage form has been approved for marketing in China.
Pipeline Development
ScienCare Pharma is also developing several other innovative products, including:
- SK1805: A biodegradable polymer pharmaceutical excipient used to wrap drugs into microspheres for controlled slow-release.
- SK1908: A new long-term drug implant used to prevent relapse of new types of drug addiction, such as methamphetamine, ketamine, and cocaine.
- SK2005: A µ-opioid receptor semi-agonist used for maintenance treatment of drug addicts. This long-acting micro-implant can be released for three months and can be administered directly through subcutaneous injection for better compliance.
- SK2007: A naltrexone implant being developed for the treatment of alcohol dependence, expected to complete Phase II clinical trials in 2023.
- Innovative Antidepressant: A new compound inhaler used to treat depression.
Future Outlook
The prioritization of ScienCare Pharma’s naltrexone implant for review by the CDE underscores the company’s commitment to addressing unmet needs in drug addiction treatment. With a robust pipeline of innovative products, ScienCare aims to enhance its market position and improve outcomes for patients struggling with addiction and mental health issues.-Fineline Info & Tech
